Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 11:54 PM
Study NCT ID:
NCT06044194
Status:
RECRUITING
Last Update Posted:
2024-04-22
First Post:
2023-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Effect of Liposomal L-Arg and Vit C Integration on Mitochondrial Function in Patients With Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001120', 'term': 'Arginine'}], 'ancestors': [{'id': 'D024361', 'term': 'Amino Acids, Basic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000599', 'term': 'Amino Acids, Diamino'}, {'id': 'D000601', 'term': 'Amino Acids, Essential'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Pilot, monocentric, national, non-pharmacological, prospective, double-blind randomized trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 56}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-19', 'studyFirstSubmitDate': '2023-09-12', 'studyFirstSubmitQcDate': '2023-09-12', 'lastUpdatePostDateStruct': {'date': '2024-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the effect of liposomal L-Arg and Vit C', 'timeFrame': '3 months', 'description': 'The primary objective of this study is to assess the effect of liposomal L-Arg and Vit C supplementation on mitochondrial function in patients with heart failure, by analysis of the viability of mitochondria isolated from peripheral blood of mononucleate cells (PBMC).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mitochondrial', 'PBMC', 'L-Arg', 'Vit C'], 'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'Pilot study to assess the effect of L-Arg and Vit C liposomal supplementation on mitochondrial function in patients with heart failure, through analysis of the viability of mitochondria isolated from peripheral blood of mononucleate cells (PBMC).', 'detailedDescription': 'Pilot, monocentric, national, non-pharmacological, prospective, double-blind randomized trial.\n\nThe primary objective of this study is to assess the effect of liposomal L-Arg and Vit C supplementation on mitochondrial function in patients with heart failure, by analysis of the viability of mitochondria isolated from peripheral blood of mononucleate cells (PBMC). Mitochondrial respiratory function of PBMC (in extensive lymphocytes and monocytes) is readily available. These cells are involved in many inflammatory diseases, including those driven by episodes of ischemia-reperfusion, which play a key role in cardiovascular alterations. In particular, the recruitment of T cells and myocardial infiltration are well described during ischemic and non-sischemic heart failure, so the mitochondrial function of PBMC could play a significant role in this immune disorderrelated during heart failure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years\n* Diagnosis of heart failure with preserved EF 45%.\n\nExclusion Criteria:\n\n* Age \\<18 years\n* Left ventricular ejection fraction \\<45%\n* Valvular heart disease\n* Previous myocardial infarction or coronary heart disease\n* Hypertension\n* Diabetes mellitus\n* Intolerance to L-arginine and liposomal vitamin C\n* Pregnancy\n* Lactation.'}, 'identificationModule': {'nctId': 'NCT06044194', 'acronym': 'Mito-HF', 'briefTitle': 'Evaluation of the Effect of Liposomal L-Arg and Vit C Integration on Mitochondrial Function in Patients With Heart Failure', 'organization': {'class': 'OTHER', 'fullName': "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico"}, 'officialTitle': 'Evaluation of the Effect of Liposomal L-Arg and Vit C Integration on Mitochondrial Function in Patients With Heart Failure', 'orgStudyIdInfo': {'id': '3189'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Treatment group', 'description': 'Once the diagnosis of heart failure is established, patients will be randomized into a double-blind treatment to receive with a 1:1 ratio an oral supplement of 1.66 g L-arginine and 500 mg of liposomal vitamin C once a day (Bioarginine. C , Pharmaceutical Damor) for 3 months (treatment group)', 'interventionNames': ['Drug: L-arginine and liposomal vitamin C']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Once the diagnosis of heart failure is established, patients will be randomized into a double-blind treatment to receive with a 1:1 ratio an oral supplement of Placebo for 3 months (control group)'}], 'interventions': [{'name': 'L-arginine and liposomal vitamin C', 'type': 'DRUG', 'description': 'Once the diagnosis of heart failure is established, patients will be randomized into a double-blind treatment to receive with a 1:1 ratio an oral supplement of 1.66 g L-arginine and 500 mg of liposomal vitamin C once a day (Bioarginine. C , Pharmaceutical Damor) for 3 months (treatment group) or an oral supplement of Placebo once a day for 3 months (control group)', 'armGroupLabels': ['Treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20122', 'city': 'Milan', 'state': 'Lombardy', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Stefano Carugo, Principal Investigator', 'role': 'CONTACT', 'email': 'stefano.carugo@policlinico.mi.it', 'phone': '+390255033579'}], 'facility': "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico", 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico", 'class': 'OTHER'}, 'collaborators': [{'name': 'DAMOR Farmaceutici S.p.a.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of the Department of Cardio-Thoracic-Vascular Diseases', 'investigatorFullName': 'Stefano Carugo', 'investigatorAffiliation': "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico"}}}}